MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0702-XTW

Device Problems Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2024

Event Type  Injury  

Event Description

It was reported that a patient presented with grade 5 degenerative tricuspid regurgitation (tr), a dilated left atrium, and a severe anterior bi-leaflet prolapse for a triclip procedure.The first clip had jumped open during initial opening in the left atrium.The first clip (xtw with lot# 40108r1100) was placed medially on the anterior and posterior leaflet segments 2 (a2p2), and a residual mr jet remained.The deployment sequence was started and the clip remained closed during first establish final arm angle (efaa).After lock line removal, second efaa was attempted and the clip opened to 30-40 degrees.Because the lock line was removed, the clip could not be removed.The clip was closed again and implanted.After clip deployment the clip opened again to 30-40 degrees.The leaflets remained fully inserted, but the mr jet increased from grade 3-4 to 4.A second clip was positioned lateral to the first clip, on the center of a2p2.During efaa (before lock line removal), the clip opened smoothly to 60 degrees.Efaa was attempted again, and the clip continuously opened to 60 degrees.Therefore, the clip delivery system (cds) was removed.A replacement device was implanted with no reported issues.A third clip (xt) was implanted medially to the first clip for stabilization.A fourth clip (ntw) was attempted to placed lateral to the second clip, but did not result in additional mr reduction.It was noted there was difficulty gasping with the fourth clip.Thus the cds was removed.The mr was reduced to grade 3-4.The patient was stable and moved to recovery.There was no clinically significant delay.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19144341
• MDR Text Key: 340607637
• Report Number: 2135147-2024-01765
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)250106(10)40108R1100
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 40108R1100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention